A Study of Yttrium-90 Radioactive Resin Microspheres to Treat Colorectal Adenocarcinoma Metastatic to the Liver

NCT01098422 | Terminated Results DMC

• 1 other identifier: 071960
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the effectiveness of radioactive microsphere infusion as a treatment for liver metastases from colon or rectal cancer. The investigators hypothesis is that the administration of microspheres between first and second line chemotherapy will increase progression-free survival time by about 2.5 months and may also improve tumor response rates to subsequent second line chemotherapy.

Conditions

Colorectal Neoplasms; Liver Neoplasms

Keywords

liver; colorectal; metastasis; carcinoma; Yttrium-90; microspheres

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria using Computerized Tomography (CT) assessment of tumor(s)

  2 years

Secondary Outcomes (4)

• Percentage of Participants Achieving Overall Survival at 6 Months

  6 Months

• Number of Participants With Responses as Determined by RECIST Criteria Using CT or Magnetic Resonance Imaging (MRI) Assessment

  2 years

• Adverse Events

  1 years

• 60 Day All-cause Mortality Rate

  60 days

Study Arms (1)

Yttrium-90 Radioactive Resin Microspheres

EXPERIMENTAL

Yttrium-90 Radioactive Resin Microspheres

Device: Yttrium-90 Radioactive Resin Microspheres

Interventions

Yttrium-90 Radioactive Resin Microspheres DEVICE

An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.

Yttrium-90 Radioactive Resin Microspheres

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed colorectal carcinoma. Liver metastasis will be confirmed by either PET scan or biopsy.
• Ability to understand and willingness to sign written informed consent
• Minimum of 18 years of age
• Liver dominant metastases measurable by CT or MRI and therefore amenable to serial assessment using RECIST criteria
• Progressive disease of metastatic colorectal carcinoma on first line combination chemotherapy with a 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) based regimen (Folinic Acid, Oxaliplatin and Fluorouracil)or failure of first line chemotherapy due to toxicity
• Candidate for second line chemotherapy with a fluorouracil, leucovorin, and irinotecan (FOLFIRI) regimen. Per standard of care, second line chemotherapy will not include Bevacizumab.
• Karnofsky Performance Score (KPS) of 70% or greater
• Life expectancy of greater than or equal to four months by investigator estimation
• Females with negative urine or serum pregnancy test
• Effective double barrier contraception for a minimum of two months following the final infusion of microspheres
• Patients who are not candidates for transarterial chemoembolization (TACE), thermal ablation or surgical resection

You may not qualify if:

• Dominant extra-hepatic disease including cerebral metastases or other extra-hepatic metastases that are symptomatic
• Large volume ascites assessed by cross sectional CT imaging
• Any chemotherapy \< 4 weeks prior to the first microsphere treatment
• Anticipated to need Avastin chemotherapy within eight weeks of day M1
• Absolute neutrophil count (ANC) \< 1.5 x 109/L
• Platelets (PLT) \< 60,000/mm3
• Hemoglobin (Hgb) \< 9.0 gm/dL
• Prothrombin time (PT) or Partial Prothrombin time (PTT) \> upper limit of normal (ULN)
• Serum Creatinine \> 2.0 mg/dL
• Forced expiratory volume (FEV1) \< 1L by baseline pulmonary function tests (ordered if investigator judges it to be clinically indicated)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper limits of normal (ULN) or total bilirubin \> 2.0 mg/dL
• History of incompetent sphincter of oddi (e.g.: sphincterotomy, biliary-enteric anastamosis, or percutaneous biliary drain)
• Severe hypoalbuminemia (albumin \< 2.0 g/dL)
• Alkaline phosphatase \> 2.5 times ULN
• Greater than 20% lung shunting (determined by the MAA - Tc 99 nuclear medicine lung shunt scan)

Sponsors & Collaborators

• Tony Reid, M.D., Ph.D.: lead
• Sirtex Medical: collaborator

Study Sites (2)

The Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Liver Neoplasms; Neoplasm Metastasis; Carcinoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Dr. Tony Reid
• Organization: UC San Diego

treid@ucsd.edu

8583531942

Study Officials

• Tony Reid, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-08

Locations

US (2)